The purpose of the International Research Scientist
Development Award (IRSDA) is to provide support and protected time (three to
five years) to advanced postdoctoral U.S. research scientists and
recently-appointed U.S. junior faculty (applicants must be at least two years
beyond conferral of doctoral degree) for an intensive, mentored research
career development experience in a low- or middle-income country (LMIC), as
defined by the World Bank (http://data.worldbank.org/about/country-classifications/country-and-lending-groups,
including "low-income," "lower-middle-income," and "upper-middle-income"
countries) leading to an independently-funded research career focused on
global health. This Funding Opportunity Announcement (FOA) invites
applications from postdoctoral research scientists and junior faculty from
any health-related discipline who propose career development activities and a
research project that is relevant to the health priorities of the LMIC under
the mentorship of LMIC and U.S. mentors.

This FOA is designed specifically for applicants proposing
to serve as the lead investigator of an independent clinical trial, a
clinical trial feasibility study, or a separate ancillary study to an existing
trial, as part of their research and career development. Applicants not
planning an independent clinical trial, or proposing to gain research
experience in a clinical trial led by another investigator, must apply to companion
FOA (PAR-18-539).

Key Dates

Posted Date

December 21, 2017

Open Date (Earliest Submission Date)

February 7, 2018

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

March 7, 2018; March 7, 2019; March 6, 2020, by 5:00 PM
local time of applicant organization. All types
of non-AIDS applications allowed for this funding opportunity
announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

Scientific Merit Review

July 2018; July 2019; July 2020

Advisory Council Review

October 2018; October 2019; October 2020

Earliest Start Date

December 2018; December 2019; December 2020

Expiration Date

March 7, 2020

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the Career Development
(K) Instructions in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.

The
overall goal of the NIH Research Career Development program is to help ensure
that a diverse pool of highly trained scientists is available in appropriate scientific
disciplines to address the Nation's biomedical,
behavioral, and clinical research needs. NIH Institutes and Centers
(ICs) support a variety of mentored and non-mentored career development award
programs designed to foster the transition of new investigators to research
independence and to support established investigators in achieving specific
objectives. Candidates should review the different career development (K) award
programs to determine the best program to support their goals. More information about Career programs may be found
at the NIH Extramural Training Mechanisms website.

Program
Description

Opportunities to advance global health research careers are
central to building a robust global health workforce, yet it remains a
challenge for researchers to establish independent international research
careers given the requisite time spent away from their home institutions.
Prolonged field experience is critical for global health research and for
establishing sustained research partnerships, but gaining this field experience
can be difficult for junior faculty, who are balancing administrative and
teaching requirements, or for individuals in standard postdoctoral positions.
The International Research Scientist Development Award (IRSDA) program
addresses this need and fills an important global health career development
gap. The IRSDA program provides opportunities to conduct mentored global health
research in low- and middle-income country (LMIC) settings and to foster
long-term research collaborations that strengthen global health research.

The objective of the IRSDA program is to prepare qualified
advanced postdoctoral research scientists and recently-appointed junior faculty
(see Eligible Individuals) for research careers that will have a significant
impact on the health-related research needs of LMICs. The award will provide
salary and research project support for a sustained period of "protected time"
(three to five years) for intensive research career development, under the
guidance of experienced U.S.-based and LMIC-based mentors, in any
health-related discipline that is relevant to the health priorities of the
LMIC.

Awardees must spend a minimum of 50% of the cumulative
effort over the project period (all years) physically in-country conducting
collaborative research at the LMIC institution. In addition, in each year of
the award, the recipient must spend a minimum of three months in the LMIC (see
In-country requirement under Eligible Individuals in Section III). Awardees are
expected to gain increased capabilities in collaborative research (i.e. team
science) skills in low-resource settings, advanced research methodology,
analysis and data management, research administrative skills, responsible
conduct of research, scientific presentation, and manuscript and grant writing.
The expectation is that through this sustained period of research career
development, awardees will launch independent global health research careers,
continue to collaborate with LMIC scientists on research that addresses the
health needs of their countries, and become competitive for new research
project grant (e.g., R01) funding.

The Fogarty International Center (FIC) is
interested in applications from individuals seeking to become independent
investigators and global health research leaders in any therapeutic or
scientific area of health priority and scientific importance to the LMIC. FIC
is dedicated to advancing the mission of the NIH by supporting and facilitating
global health research conducted by U.S. and international investigators,
building partnerships between health research institutions in the U.S. and
abroad, and training the next generation of scientists to address global health
needs. FIC supports a diversity of research and research training grants that
advance basic to implementation science with a particular focus on LMICs. The
IRSDA is responsive to the FIC Strategic Plan to build research capacity
through individuals, institutions and networks by building future research
leaders in the U.S. and in LMICs.

The NCI's Center for Global Health (CGH) will support intensive, mentored research career development for early stage
investigators committed to a cancer research career. CGH is particularly
interested in applications that include well-designed epidemiology studies on
common risk factors (social, biological, occupational, environmental) for
cancer, clinical and translational research, detection and diagnosis, health
surveillance including cancer registry development, knowledge sharing,
implementation science, informatics, mHealth, or malignancies associated with
chronic infection. The research activities should be specifically focused on
cancer. The career development plan should include training in advanced
scientific skills, research methodology, data management and analysis, grant
and manuscript writing, and research administration skills that are appropriate
for the LMIC. The proposed career development and mentoring must be focused on
developing independent researchers in the field of cancer in a manner that
increases the research capacity at the LMIC institution. Mentors should have a
track record of research in cancer.

Candidates are encouraged to review answers to frequently
asked questions about the IRSDA K01 program at IRSDA FAQs,
which will be updated on a regular basis.

Individuals who are unable to meet the requirement to spend
a minimum of 50% of the cumulative effort over the total project period (all
years) and the additional requirement to spend a minimum of three months each
year conducting research physically in the LMIC are encouraged to consider
other NIH career development awards (see https://researchtraining.nih.gov/programs/career-development),
many of which support global health research in LMICs.

Note: This Funding Opportunity Announcement (FOA) is designed
specifically for applicants proposing to serve as the lead investigator of an
independent clinical trial, a clinical trial a feasibility study, or a separate
ancillary study to an existing trial, as part of their research and career
development. Applicants not planning an independent clinical trial, or
proposing to gain research experience in a clinical trial led by another
investigator, must apply to companion FOA (PAR-18-539).

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

Award budgets are composed of salary and other
program-related expenses, as described below.

Award Project Period

The total project period should be a minimum of 3 years
and may not exceed 5 years.

Other Award Budget
Information

Salary

NIH will contribute up to $ 75,000 per year toward the salary of the
career award recipient. Further guidance on budgeting for career development
salaries is provided in the SF424 (R&R) Application Guide.

NIH will contribute up to $ 30,000 per year toward the research
development costs of the award recipient, which must be justified and
consistent with the stage of development of the candidate and the proportion
of time to be spent in research or career development activities. Research
development costs include, but are not limited to, supplies, equipment,
technical personnel, non-degree related tuition or registration fees for
activities related to the proposed career development plan, fees for
statistical and computational services, and travel to research sites,
research meetings, or training, as detailed in Section IV.

Salary for mentors, secretarial and administrative
assistants, etc. is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities &
Administrative [F&A] Costs) are reimbursed at 8% of modified total direct
costs.

NIH grant policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made from this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that applicants
be issued a DUNS number. After obtaining a DUNS number, applicants can begin
both SAM and eRA Commons registrations. The same DUNS number must be used for
all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to
complete the eRA Commons registration. Organizations can register with the eRA
Commons as they are working through their SAM or Grants.gov registration. eRA
Commons requires organizations to identify at least one Signing Official (SO)
and at least one Program Director/Principal Investigator (PD/PI) account in
order to submit an application.

Grants.gov – Applicants must have an active DUNS number and SAM registration in order to
complete the Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.

Mentors

The primary mentor at the U.S. institution and the primary
LMIC mentor must have eRA Commons accounts. Obtaining an eRA Commons
account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any candidate with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her mentor and organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status).

Current and former PDs/PIs (including Multiple PDs/PIs) on
NIH research project (R01), program project (P01), research training (D43), or
center (P50) grants, sub-projects of program project (P01) or center (P50)
grants, other major individual career development awards (e.g., K01, K07, K08,
K22, K23, K25, K76, K99/R00), or the equivalent to these grants/awards
(including non-NIH equivalent grants/awards from other research funding
organizations) are not eligible. Current and former PDs/PIs (including Multiple
PDs/PIs) of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21),
Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.
Individuals supported by institutional K awards (K12 or KL2) remain eligible
but cannot exceed 6 years of combined institutional K plus individual K01
funding. A candidate for this award may not concurrently apply for or have an
award pending for any other NIH career development award.

Candidates for this award must have a research or
health-professional doctoral degree (including PhD, MD, DO, DC, ND, DDS, DMD,
DVM, ScD, DNS, PharmD or equivalent doctoral degrees) received at least two
years prior to the application deadline and have research experience beyond their
doctoral training.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct, and each is from a
different candidate.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. An individual may not have two or
more competing NIH career development applications pending review concurrently.
In addition, NIH will not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Candidates may submit research project grant (RPG)
applications concurrently with the K application. However, any concurrent RPG
application may not have substantial scientific and/or budgetary overlap with the
career award application. K award recipients are encouraged to obtain funding
from NIH or other Federal sources either as a PD/PI on a competing research
grant award or cooperative agreement, or as project leader on a competing
multi-project award as described in NOT-OD-08-065.

Level of Effort

At the time of award, the candidate must have a "full-time"
appointment at the academic institution. Candidates are required to commit a
minimum of 75% of full-time professional effort (i.e., a minimum of 9
person-months) to their program of career development during the mentored
phase. Candidates may engage in other duties as part of the remaining 25% of
their full-time professional effort not covered by this award, as long as such
duties do not interfere with or detract from the proposed career development
program.

Candidates who have VA appointments may not consider part of
the VA effort toward satisfying the full time requirement at the applicant
institution. Candidates with VA appointments should contact the FIC Program
Officer prior to preparing an application to discuss their eligibility. Under
certain circumstances, an awardee may submit a written request to the awarding
component requesting a reduction in minimum required percent effort, which will
be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

In-country
requirement: Awardees must spend a minimum of 50% of their
cumulative effort over the total project period (all years) physically
in-country conducting research at the LMIC institution. In addition, in each
year of the award, awardees must spend a minimum of three months at the LMIC
institution. For example, a candidate with 75% effort on a 5-year IRSDA K01
must spend 22.5 months at the LMIC institution.

Mentors

Before submitting the application, the candidate must
identify a primary mentor at the U.S. applicant institution and a primary
mentor at the collaborating LMIC institution who are accomplished investigators
in the research area proposed and have experience in successful development of
independent investigators. Together, the two primary mentors will
supervise the proposed career development and research experience. The primary
LMIC mentor should not be a U.S. citizen who holds a joint appointment at the
LMIC institution. The primary mentors should be active investigators in the
area of the proposed research and committed both to the career development of
the candidate and direct supervision of the candidate's research. The primary
mentors must document the availability of sufficient research support and
facilities for the candidate's research. Candidates are encouraged to identify
additional co-mentors to form a mentoring team, if this is deemed advantageous
for providing expert advice in all aspects of the research career development
plan. The candidate must work with all mentors (primary and co-mentors) in
preparing the application.

The mentor(s) or mentoring team must demonstrate appropriate
expertise, experience, and ability to guide the applicant in the organization,
management and implementation of the proposed research and clinical trial.

Institutional Environment

The U.S. and LMIC institutions must have a strong,
well-established record of research and career development activities and
faculty qualified to serve as mentors in biomedical, behavioral, or clinical
research.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Career Development
(K) Instructions in the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for review.

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF 424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed. Include the applicant institution and all of the
collaborating institutions, both U.S. and LMIC, as performance sites.

Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guide
must be followed. Both the primary US and primary LMIC mentor must insert
"Other" or "Other Professional" in the Project Role field,
and enter "Mentor" in the Other Project Role Category field.

When listing other individuals with a substantive role in
the project, clearly label roles to distinguish "Co-Mentor",
"Consultant", "Collaborator", etc.

When listing the applicant's research support in the
Biographical Sketch, clarify PD/PI status (direct recipient) of awards.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must
be followed, with the following additional instructions:

Applicants should identify specific expenses such as: (a)
non-degree related tuition or registration fees for specific PD/PI career
development activities; (b) research expenses such as supplies, equipment and
technical personnel; (c) statistical and computational services, including
technical personnel and computer time; (d) mentor and grantee communication costs;
and (e) PD/PI travel and per diem expenses to field research sites,
collaborating institutions, research or networking meetings, or research skills
workshops or courses in the appropriate budget form category.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is
comprised of the following sections:

Candidate

Research Plan

Other Candidate Information

Mentor, Co-Mentor, Consultant, Collaborators

Environment & Institutional Commitment to the Candidate

Other Research Plan Sections

Appendix

All instructions in the SF424 (R&R) Application Guide must
be followed.

Candidate Section

All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:

Candidate
Information and Goals for Career Development

Candidate's Background

Describe the candidate's commitment to a global health-related
research career.

Describe prior training and research experience beyond doctoral
training and how it relates to the objectives and long-term global health
research career plans of the candidate.

Provide evidence of the candidate's potential to develop into a
successful independent global health researcher (such as lead authorship of
and/or significant contribution to research publications in peer-reviewed
journals, presentations at international meetings, prior research interests and
experience, research fellowships, and letters of reference).

Justify the candidate's need for an additional mentored research
experience to become an independent research scientist.

Describe all the candidate's professional responsibilities at the
grantee institution and elsewhere and show the relation of these
responsibilities to the proposed activities on the career development award.

If applicable, describe the candidate's prior clinical trials research
efforts, prior research interests and experience.

Career Goals and Objectives

Describe the candidate's career goals and the specific objectives
to reach each goal under this award, indicating linkages to prior experience
and current research support.

Explain how the career development award will contribute to
career goals, and further the candidate's global health research career.

The candidate must demonstrate they have received training or
will participate in courses such as: data management, epidemiology, study
design (including statistics), hypothesis development, drug development, etc.,
as well as the legal and ethical issues associated with research on human
subjects and clinical trials.

Candidate's Plan for Career
Development/Training Activities During Award Period

Describe a systematic plan: (1) that shows a logical progression
from prior research and training experiences to the research and career
development activities proposed; (2) that justifies the need for further
research career development to become an independent researcher; and (3)
utilizes the relevant field, clinical, research and educational resources of
the U.S. and LMIC institutions. The candidate and the mentors are jointly
responsible for the preparation of the career development plan.

The plan should include a description of the primary mentors, any
secondary co-mentors, and any collaborators, contributors or consultants, as
appropriate for the research and career development of the candidate.

Provide a detailed description of the career development
activities, including plans to obtain the necessary research skills and
experience to launch an independent global health research career. The
description of the career development plan should include items such as
advanced level courses, seminars, and opportunities for collaboration and
interaction with other scientists, especially in the proposed LMIC. Training in
career skills such as grant-writing and making effective scientific
presentations, is strongly encouraged. The career development plan must
be tailored to the needs of the individual candidate and the ultimate goal of
achieving independence as a researcher.

Describe a career development plan that will maximize use of U.S.
and LMIC research institutional environments, including available facilities
and resources.

Describe the professional responsibilities/activities including
other research projects beyond the minimum required 9 person-months (75%
full-time professional effort) commitment to the career award. Explain
how these responsibilities/activities will help ensure career progression to
achieve independence as an investigator.

For junior faculty, describe how this award will relieve the
candidate of current duties so that a greater portion of the candidate's effort
(at least 9 person-months, equivalent to 75% full-time professional effort) may
be devoted to research and related career development activities.

For postdocs, describe how the award would provide additional
research and career development opportunities beyond the standard postdoctoral
experience.

Describe how the candidate plans to fulfill the requirement that
he/she spend at least 50% of cumulative effort over the total project period
(all years) physically in-country conducting research at the LMIC site AND in
each year of the grant, the candidate will meet the requirement to spend a
minimum of three months in the LMIC. A timeline outlining time in country is
strongly recommended.

Applicants are encouraged to describe plans for outreach and
dissemination of research findings both in the LMIC and in the U.S.

Research Plan Section

All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:

Research
Strategy

Applicants may propose research in any global health related
discipline.

A sound global health research project that addresses an area of
scientific importance to the LMIC and is consistent with the candidate's level
of research development and objectives of his/her career development plan must
be provided. The research description should demonstrate the quality of the
candidate's research capabilities thus far, and the proposed research question,
design and methodology should be novel, scientifically significant and creative
in approach.

Applicants should provide a detailed explanation of the relevance
of the proposed research to the health priorities of the LMIC.

The application must also describe the relationship between the
mentors' research and the candidate's proposed research plan. Although the
research strategy may be related to the research activities of the mentors, it
should not be a duplication of the mentors' research.

Applicants are encouraged to propose research related to ongoing
NIH and U.S. government-supported research initiatives in the LMIC.

Applicants proposing a clinical trial, ancillary or feasibility
study should describe the planned analyses and statistical approach and how the
expected analytical approach is suited to the available resources, proposed
study design, scope of the project, and methods used to assign trial
participants and deliver interventions.

If proposing an ancillary study to an ongoing clinical trial,
provide a brief description of its relationship to the larger clinical trial.

If proposing a feasibility study, to begin to address a clinical
question, provide justification why this is warranted and how it will
contribute to the overall goals of the research project including planning and
preliminary data for future, larger scale clinical trials.

Describe the proposed timelines for the proposed clinical trial,
feasibility or ancillary study, including any potential challenges and
solutions (e.g., enrollment shortfalls or inability to attribute causal
inference to the results of an intervention when performing a small feasibility
study).

Describe how the proposed clinical trial or ancillary study will
test the safety, efficacy or effectiveness of an intervention that could lead
to a change in clinical practice, community behaviors or health care policy
(This would not apply to a feasibility study).

Training
in the Responsible Conduct of Research

All applications must include a plan to fulfill NIH requirements
for instruction in the Responsible Conduct of Research (RCR). See SF424
(R&R) Application Guide for instructions. Applicants are strongly
encouraged to include courses and activities offered at the LMIC site , if
applicable, to get a perspective of the issues involved in RCR where they will
be engaged in research.

Mentor, Co-Mentor, Consultant,
Collaborators Section

All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:

Statements from the primary U.S. mentor at the applicant
institution, the primary LMIC mentor, as well as any co-mentors, are expected
to provide 1) an assessment of the candidate's qualifications and potential for
an independent global health research career; 2) information on the mentor's
research qualifications and previous experience as a research supervisor; 3) a
plan that describes the nature of the supervision and mentoring that will occur
during the proposed award period; 4) a plan for career progression for the
candidate to move from the mentored stage of his/her career to independent
research investigator status during the project period of the award; and 5) a
plan for monitoring and evaluating the candidate's research, publications, and
progression towards independence.

Together, the mentors should provide evidence of sufficient
independent research support to cover the costs of the proposed research
project in excess of the allowable costs of this award. Each mentor
statement should describe the research support, if any, that will be available
to support the proposed candidate research project.

Where feasible, women, individuals from diverse racial and ethnic
groups, and individuals with disabilities should be involved as mentors to
serve as role models.

The primary U.S. Mentor statement should include a statement that
the candidate will commit at least 9 person-months (75% of full-time
professional effort) to the career development program and related career
development activities.

Mentor statements should include a statement that the candidate
will meet the time-in-country requirement (50% of requested effort over the
entire award period).

Mentor statements should clearly describe how they will
coordinate mentoring of the candidate with other proposed mentors, both primary
and secondary co-mentors.

Mentor statements should describe the mechanism(s) and frequency
of communication with the candidate, including the frequency of face-to-face
meetings.

Both primary mentors (U.S. and LMIC) must agree to provide annual
evaluations of the candidate's progress as required in the annual progress
report.

The mentor or mentoring team must provide evidence of expertise,
experience, and ability to guide the applicant in the organization, management
and implementation of the proposed clinical trial, ancillary or feasibility
study and help him/her to meet timelines.

Letters of Support from Collaborators,
Contributors and Consultants

Signed statements must be provided by all additional
collaborators and/or consultants confirming their participation in the project
and describing their specific roles. Collaborators and consultants generally do
not need to provide their biographical sketches unless also listed as
senior/key personnel. However, information should be provided clearly
documenting the appropriate expertise in the proposed areas of
consulting/collaboration. Collaborators/consultants are generally not directly
involved in the development of the career of the candidate as an independent
researcher.

The LMIC Institutional Commitment letter should also be included
in this section, following page limit requirements for this section. It should
provide a statement of commitment to the candidate's development into a
productive, independent researcher and provide assurances that appropriate time
and support for the proposed mentor(s) and/or other staff consistent with the
career development plan will be provided.

All letters should be combined and submitted as a single PDF.

Environmental and Institutional
Commitment to the Candidate

All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:

Description
of Institutional Environment

Both the applicant U.S. institution and the LMIC institution must
provide descriptions of the scientific environment, resources, and facilities
that will be available to the candidate.

The U.S. and LMIC institutions must document strong,
well-established research and career development programs related to the
candidate's area of interest, and key faculty members and other investigators
capable of productive collaboration with the candidate.

Describe the resources and facilities that will be available to
the candidate, including any clinical trial-related resources, such as
specialized administrative, data coordinating, enrollment, and
laboratory/testing support. If applicable, include a description of the
resources and facilities available at international sites.

Institutional
Commitment to the Candidate's Research Career Development

Both the applicant U.S. institution and the LMIC institution must
provide statements of commitment to the candidate's development into a
productive, independent global health investigator and to meeting the
requirements of this award. It should be clear that the institutional
commitment to the candidate is not contingent upon receipt of this career
development award.

The applicant U.S. institution must provide assurance that the
candidate will be able to devote a minimum of 9 person-months (75% of full-time
professional effort) to the development of their research program. The
remaining effort should be devoted to activities related to the development of
the candidate's career as an independent scientist, e.g. clinic responsibilities,
teaching and administration, and/or additional research activities.

The U.S. institution should provide assurance that the candidate
will be able to spend at least 50% of the cumulative effort over the project
period at the LMIC site, conducting research and career development activities.

Provide assurance that the candidate will have appropriate office
and laboratory space, equipment, and other resources and facilities (including
access to clinical and/or other research populations) to carry out the proposed
research plan.

Provide assurance that appropriate time and support will be
available for any proposed mentor(s) and/or other staff consistent with the
career development plan.

The LMIC Institutional Commitment letter should be submitted via
"Letters of Support from Collaborators, Contributors, and
Consultants", following page limit requirements. The U.S. Institutional
Commitment letter should be submitted here.

Appendix

Limited items are allowed in the Appendix.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide; any instructions provided here are in addition to the SF424
(R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical
research, and/or clinical trials follow all instructions for the PHS Human
Subjects and Clinical Trials Information form in the SF424 (R&R)
Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects
Involved?" on the R&R Other Project Information form, you must include at
least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials
Information form or a Delayed
Onset Study record.

Study
Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

Delayed
Onset Study

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

Reference Letters

Candidates must carefully follow the SF424 (R&R)
Application Guide, including the time period for when reference letters will
be accepted. Applications lacking the appropriate required reference
letters will not be reviewed. This is a separate process from submitting an
application electronically. Reference letters are submitted directly through
the eRA
Commons Submit Referee Information link and not through Grants.gov.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1.
Section III.1 for information regarding the requirement for obtaining a unique
entity identifier and for completing and maintaining active registrations in
System for Award Management (SAM), NATO Commercial and Government Entity
(NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH's electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date. and time. If a Changed/Corrected application is
submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the
NIH Policy on Late Application Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number
it provides on the application is the same number used in the organization's
profile in the eRA Commons and for the System for Award Management (SAM).
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.

Important Update: See NOT-OD-18-229 for updated review language for due dates on or after January 25, 2019.

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers should provide their assessment of the likelihood that
the proposed career development and research plan will enhance the candidate's
potential for a productive, independent scientific research career in a
health-related field, taking into consideration the criteria below in
determining the overall impact score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

The reviewers will consider that the clinical trial may
include study design, methods, and intervention that are not by themselves
innovative, but address important questions or unmet needs. Reviewers should
also consider the scope of the clinical trial relative to the available
resources, including the possibility that research support provided through K
awards may be sufficient to support only small feasibility studies.

Candidate

Does the candidate have the potential to develop as an
independent and productive global health researcher addressing scientifically
significant topics that reflect the health priorities of the LMIC?

Are the candidate's prior training and research experience
appropriate for this award?

Is the candidate's academic, clinical (if relevant), and research
record of high quality?

Is there evidence of the candidate's commitment to meeting the
program objectives to become an independent global health researcher?

Do the letters of reference address the above review criteria,
and do they provide evidence that the candidate has a high potential for
becoming an independent global health investigator?

Does the candidate justify the need for three to five years of
mentored research experience in order to become an independent scientist?

Does the candidate have the potential to organize, manage, and
implement the proposed clinical trial, feasibility or ancillary study?

Does the candidate have training (or plans to receive training)
in data management and statistics including those relevant to clinical trials?

Career
Development Plan

What is the likelihood that the plan will contribute
substantially to the scientific development of the candidate, leading to
research independence?

Are the candidate's prior training and research experience
appropriate for this award?

Are the content, scope, phasing, and duration of the career
development plan appropriate when considered in the context of prior
training/research experience and the stated training and research objectives
for achieving research independence?

Are there adequate plans for mentors to monitor and evaluate the
candidate's research and career development progress?

Does the career development plan demonstrate a clear commitment
to a global health research career in LMIC settings?

Is the amount of time proposed at the LMIC site apppropriate for
the candidate's research and career development goals, and does it meet the
program requirement to spend at least and does it meet the program requirement
to spend at least 50% of the cumulative effort over the project period (all
years) and at least three months each year physically in-country conducting
collaborative research at the LMIC institution. In addition, in each year of
the award, the recipient must spend a minimum of three months in the LMIC?

Research Plan

Is there a strong scientific premise for the project?

Has the candidate presented strategies to ensure a robust and
unbiased approach, as appropriate for the work proposed?

Has the candidate presented adequate plans to address relevant
biological variables, such as sex, for studies in vertebrate animals or human
subjects?

Are the proposed research question, design, and methodology
novel, scientifically significant, creative, and of technical merit?

Is the research plan relevant to the candidate's research career
objectives?

Is the research plan appropriate to the candidate's stage of
research development and as a vehicle for developing the research skills
described in the career development plan?

Will the proposed research lead to an independent line of
research for the candidate?

Does the research plan address an area of health priority and
scientific importance to the LMIC?

Are the scientific rationale and need for a clinical trial,
feasibility or ancillary study well supported by preliminary data, clinical
and/or preclinical studies, or information in the literature or knowledge of
biological mechanisms?

If proposing a small feasibility study, is the study warranted
and will it contribute to planning and preliminary data needed for design of
future larger scale clinical trials?

Is the clinical trial or ancillary study necessary for testing
the safety, efficacy or effectiveness of an intervention, or in the case of a
feasibility study necessary to establish feasibility of future clinical trial?

Is the study design justified and relevant to the clinical,
biological, and statistical hypothesis(es) being tested?

Are the plans to standardize, assure quality of, and monitor
adherence to, the protocol and data collection or distribution guidelines
appropriate?

Are planned analyses and statistical approach appropriate for the
proposed study design and methods used to assign participants and deliver
interventions?

For trials focusing on mechanistic, behavioral, physiological,
biochemical, or other biomedical endpoints, is this trial needed to advance
scientific understanding?

Mentors, Co-Mentor(s),
Consultant(s), Collaborator(s)

Are the primary U.S. mentor's and the primary LMIC mentor's
research qualifications in the area of the proposed research appropriate?

Do the primary mentors and any co-mentors adequately address the
candidate's potential and his/her strengths and areas needing improvement?

Is there adequate description of the quality and extent of the
primary U.S. mentor's and the primary LMIC mentor's proposed role in providing
guidance and advice to the candidate?

Are the mentor's descriptions of the elements of the research career
development activities, including formal course work, adequate?

Is there evidence of the mentors', consultant's, and/or
collaborator's previous experience in fostering the development of independent
researchers in the LMIC proposed?

Is there evidence of previous research productivity and
peer-reviewed support?

Is active/pending support relevant to the candidate's proposed
research project appropriate and adequate?

Are there adequate plans for monitoring and evaluating the career
development awardee's progress toward independence?

If a Mentoring Team is proposed, are the qualifications of the
members, the quality of the planned roles for advice, and scheduled
meeting frequency of the Mentoring Team with the candidate adequate?

Does the mentor or mentoring team have the expertise, experience,
and ability to guide the applicant in the organization, management and
implementation of the proposed clinical trial, ancillary, or feasibility study
and help him/her to meet timelines?

Environment
& Institutional Commitment to the Candidate

Is there clear commitment of the applicant U.S. institution to
ensure that a minimum of 9 person-months (75% of the candidate's full-time
professional effort) will be devoted directly to the research and career
development activities described in the application, with the remaining percent
effort being devoted to an appropriate balance of research, teaching,
administrative, and clinical responsibilities?

Is there clear commitment of the applicant U.S. institution to
ensure that the candidate will be able to spend the required time at the LMIC
site (a minimum of 50% of the cumulative effort over the project (all years)
and a minimum of 3 months each year)?

Are the institutional commitments (U.S. and LMIC) to the career
development of the candidate and for the mentors appropriately strong?

Are the research facilities, resources and training opportunities
at the U.S. and LMIC institutions, including faculty capable of productive
collaboration with the candidate adequate and appropriate?

Is the environment for scientific and professional development of
the candidate of high quality?

Is there assurance that the institution intends the candidate to
be an integral part of its research program as an independent investigator?

Are the administrative, data coordinating, enrollment and
laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and
ability to conduct the trial feasibility or ancillary study at the proposed
site(s) or centers? If applicable, are there plans to add or drop enrollment
centers, as needed, appropriate?

If international site(s) is/are proposed, does the application
adequately address the complexity of executing the clinical trial?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Study
Timeline for Clinical Trials

Is the study timeline described in
detail, taking into account start-up activities, the anticipated rate of
enrollment, and planned follow-up assessment? Is the projected timeline
feasible and well justified? Does the project incorporate efficiencies and
utilize existing resources (e.g., CTSAs, practice-based research networks,
electronic medical records, administrative database, or patient registries) to
increase the efficiency of participant enrollment and data collection, as
appropriate?

Are potential challenges and
corresponding solutions discussed (e.g., strategies that can be implemented in
the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3)
potential benefits to the subjects and others, (4) importance of the knowledge
to be gained, and (5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: (1)
the justification for the exemption, (2) human subjects involvement and
characteristics, and (3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion
of Women, Minorities, and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate
Animals

The committee
will evaluate the involvement of live vertebrate animals as part of the
scientific assessment according to the following criteria: (1) description of
proposed procedures involving animals, including species, strains, ages, sex,
and total number to be used; (2) justifications for the use of animals versus
alternative models and for the appropriateness of the species proposed; (3)
interventions to minimize discomfort, distress, pain and injury; and (4)
justification for euthanasia method if NOT consistent with the AVMA Guidelines
for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as
they would any other application proposing the use of vertebrate animals. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Training in the
Responsible Conduct of Research

All applications for support under this FOA must
include a plan to fulfill NIH requirements for instruction in the Responsible
Conduct of Research (RCR). Taking into account the level of experience of the
applicant, including any prior instruction or participation in RCR as
appropriate for the applicant's career stage, the reviewers will evaluate the
adequacy of the proposed RCR training in relation to the following five
required components: 1) Format - the required format of instruction,
i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a
plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data
management, human subjects and animal use, laboratory safety, research
misconduct, research ethics; 3) Faculty Participation - the role of the
mentor(s) and other faculty involvement in the fellow's instruction; 4) Duration
of Instruction - the number of contact hours of instruction (at least eight
contact hours are required); and 5) Frequency of Instruction –instruction
must occur during each career stage and at least once every four years. Plans
and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and
the summary statement will provide the consensus of the review committee. See
also: NOT-OD-10-019.

Select Agent
Research

Reviewers will assess the information provided in
this section of the application, including (1) the Select Agent(s) to be used
in the proposed research, (2) the registration status of all entities where
Select Agent(s) will be used, (3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and (4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key
biological and/or chemical resources, reviewers will comment on the brief plans
proposed for identifying and ensuring the validity of those resources.

Budget and
Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned to the Fogarty International
Center. Applications will compete for available funds with all other
recommended applications . Following initial peer review, recommended applications
will receive a second level of review by the Fogarty International Center
Advisory Board. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Geographic balance considerations.

Relevance to the interests of co-funding organizations.

Potential to contribute to other NIH- and U.S.
government-supported research initiatives in LMICs.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee's business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Individual awards are based on the application submitted to,
and as approved by, the NIH and are subject to the IC-specific terms and
conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more
clinical trials, or a new ancillary study to an ongoing clinical trial. By law
(Title VIII, Section 801 of Public Law 110-85), the lead investigator must
register and submit results information for certain "applicable clinical
trials" on the ClinicalTrials.gov Protocol Registration and Results System
Information Website (https://register.clinicaltrials.gov). NIH expects
registration of all trials whether required under the law or not. For more
information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee
Approval: Grantee institutions must ensure that the application as well as all
protocols are reviewed by their IRB or IEC. To help ensure the safety of
participants enrolled in NIH-funded studies, the awardee must provide NIH
copies of documents related to all major changes in the status of ongoing
protocols.

Data and Safety Monitoring Requirements: The NIH policy for
data and safety monitoring requires oversight and monitoring of all
NIH-conducted or -supported human biomedical and behavioral intervention
studies (clinical trials) to ensure the safety of participants and the validity
and integrity of the data. Further information concerning these requirements is
found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the
application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption
Requirements: Consistent with federal regulations, clinical research projects
involving the use of investigational therapeutics, vaccines, or other medical
interventions (including licensed products and devices for a purpose other than
that for which they were licensed) in humans under a research protocol must be
performed under a Food and Drug Administration (FDA) investigational new drug
(IND) or investigational device exemption (IDE).

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person's race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator's scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of
Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to
theFederal Awardee Performance and Integrity Information System
(FAPIIS) requirements. FAPIIS requires Federal award making officials to
review and consider information about an applicant in the designated integrity
and performance system (currently FAPIIS) prior to making an award. An
applicant, at its option, may review information in the designated integrity
and performance systems accessible through FAPIIS and comment on any information
about itself that a Federal agency previously entered and is currently in
FAPIIS. The Federal awarding agency will consider any comments by the
applicant, in addition to other information in FAPIIS, in making a judgement
about the applicant's integrity, business ethics, and record of performance
under Federal awards when completing the review of risk posed by applicants as
described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed
by applicants." This provision will apply to all NIH grants and cooperative
agreements except fellowships.

3. Reporting

When multiple years are
involved, awardees will be required to submit the Research Performance Progress
Report (RPPR) annually and financial statements as required in the NIH Grants
Policy Statement. The Supplemental Instructions for Individual Career
Development (K) RPPRs must be followed. The Mentor's Report must include an
annual evaluation statement of the candidate's progress.

A final RPPR, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation under
Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301,
307, and 405 of the Public Health Service Act as amended (42 USC 241, 284, and
287(b)) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and
92.